Drug monitoring and regulation systems and methods

Abstract

Systems and methods for monitoring and regulating the concentration of a drug in a subject are provided. A method may include administering to a subject a first dose of a pharmaceutical composition at a first time point. Next, a concentration of an active ingredient of the pharmaceutical composition or a metabolite thereof, or a biological marker indicative of the concentration of the pharmaceutical composition in the subject, may be determined from a biological sample of the subject with the aid of a point of care system. A second dose of the pharmaceutical composition may be administered to the subject at a second time point. The second dose and/or the interval between the first and second time points may be determined based on the concentration of the pharmaceutical composition in the subject.

1 - 4 . (canceled) 
     
     
         5 . A method for administering a pharmaceutical composition to a subject, comprising:
 administering to a subject a second dose of said pharmaceutical composition at a third time point, wherein said second dose and said third time point is determined by:   (a) administering to said subject a first dose of a pharmaceutical composition at a first time point;   (b) obtaining a biological sample of said subject with the aid of a point of care system;   (c) measuring, with the aid of the point of care system and the user of said biological sample, concentration of an active ingredient of said pharmaceutical composition or a metabolite thereof, or a biological marker indicative of the concentration of said pharmaceutical composition present in said subject at a second time point; and
 (d) calculating, with the aid of a computer processor, dosage and/or time interval between dosages based on said concentration measured in step (c), thereby determining said second dose and/or the interval between said second and third time points. 
   
     
     
         6 . The method of claim  1 , further comprising:
 comparing said concentration to one or more set-point concentrations; and   calculating the second dose based on the difference between said concentration and the one or more set-point concentrations.   
     
     
         7 . The method of  claim 6 , wherein comparing the concentration to one or more set-point concentrations comprises comparing the concentration to a subject-specific maximum drug concentration and a subject-specific minimum drug concentration, wherein the subject-specific maximum and subject-specific minimum drug concentrations are determined based on maximum concentrations and minimum concentrations of a plurality of subject-specific drug concentration profiles. 
     
     
         8 . (canceled) 
     
     
         9 . The method of  claim 6 , wherein comparing the drug concentration to one or more set-point concentrations comprises comparing the drug concentration to an average set point concentration, wherein the average set-point concentration is a time-averaged set-point concentration. 
     
     
         10 . (canceled) 
     
     
         11 . The method of  claim 6 , wherein the one or more set-point concentrations are subject-specific set-point concentrations. 
     
     
         12 . The method of claim  1 , wherein step (c) comprises measuring the blood concentration of said active ingredient of said pharmaceutical composition or a metabolite thereof. 
     
     
         13 . (canceled) 
     
     
         14 . (canceled) 
     
     
         15 . The method of claim  1 , further comprising monitoring, with the aid of a computer processor, the progression of a health condition of said subject in response to administering said first dose and/or said second dose. 
     
     
         16 . The method of  claim 15 , further comprising adjusting said first dose, said second dose and/or said interval based on said monitoring. 
     
     
         17 . A method for monitoring the concentration of a pharmaceutical composition in a subject, comprising:
 (a) obtaining, with the aid of a point of care system, a biological sample from a subject who has received a first dose of a pharmaceutical composition at a first time;   (b) measuring, with the aid of the point of care system and the user of the said biological sample, concentration of an active ingredient of said pharmaceutical composition or a metabolite thereof, or a biological marker indicative of the concentration of said pharmaceutical composition present in said subject; and   (c) calculating, with the aid of a computer processor, dosage and/or time interval between dosages based on said concentration measured in step (b); and   (d) prescribing to the subject a second dose of the pharmaceutical composition at a second time according to said calculated dosage and/or time interval of step (c).   
     
     
         18 . The method of  claim 17 , further comprising:
 comparing, with the aid of a processor, said measured concentration of step (c) to the one or more set-point concentrations; and   calculating the second dose based on the difference between said measured concentration and the one or more set-point concentrations.   
     
     
         19 . The method of  claim 18 , wherein comparing said concentration to the one or more set-point concentrations comprises comparing said concentration to a subject-specific maximum concentration and a subject-specific minimum concentration. 
     
     
         20 . The method of  claim 19 , wherein the subject-specific maximum and subject-specific minimum blood concentrations are determined based on maximum concentrations and minimum concentrations of a plurality of subject-specific blood concentration profiles. 
     
     
         21 . The method of  claim 18 , wherein comparing said concentration to the one or more set-point concentrations comprises comparing the concentration to an average set point concentration, wherein the average set-point concentration is a time-averaged set-point concentration. 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 18 , wherein the one or more set-point concentrations are subject-specific set-point concentrations, wherein said concentration is measured in real-time. 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . The method of  claim 17 , further comprising monitoring, with the aid of a computer processor, the progression of a health condition of said subject in response to prescribing said first dose and/or said second dose. 
     
     
         28 . The method of  claim 27 , further comprising determining said first dose, said second dose and/or said predetermined interval based on said monitoring. 
     
     
         29 . (canceled) 
     
     
         30 . A system for monitoring a concentration of a drug in a subject, comprising:
 a point of care module for monitoring, with the aid of a computer processor, a concentration of an active ingredient of a pharmaceutical composition or a metabolite thereof, or a biological marker indicative of the concentration of said pharmaceutical composition in said subject:   a drug monitoring module in communication with the point of care module, the drug monitoring module for providing one or more set point concentrations of an active ingredient of a pharmaceutical composition or a metabolite thereof in the subject; and   a medical record module comprising records of doses in time, the medical record module for storing and providing a medical record of the subject.   
     
     
         31 . The system of  claim 30 , wherein the drug monitoring module provides the one or more set point concentrations with the aid of i) a predetermined table, or ii) a learning engine. 
     
     
         32 . (canceled) 
     
     
         33 . The system of  claim 30 , further comprising an output module for providing one or more instructions to the subject, wherein the one or more instructions are selected from dose instructions and administration instructions for a pharmaceutical composition. 
     
     
         34 . (canceled) 
     
     
         35 . The system of  claim 30 , further comprising a server in communication with the point of care module and the medical records module. 
     
     
         36 - 38 . (canceled)